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Who heeds the heeding presumption?

We’ve made no secret of our distaste for the so called “heeding presumption” – that juries may presume that any alternative “adequate” warning would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber). We have a topic header on this subject with multiple posts decrying such presumptions, both generally and in the particular context of prescription medical products.

The biggest conceptual problem is that there are two fundamentally different kinds of warnings. Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t. Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you). Most step-by-step directions also fall in this category.

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about. Rather, with prescription-only products, most of the relevant risks arise whenever the product is used. A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product. The only way to avoid the risk is not to use the product at all. All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place. For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (applying Mississippi law), which you can find later in this post.

What happens when a heeding presumption is imposed concerning a risk warning? In that situation, “heeding” the warning can only mean not using the product at all, because that’s the only way to avoid the risk. So applying a “heeding presumption” to an inherent risk lets plaintiffs argue, in effect, that the product should never have been sold – that every “reasonable” person would have “heeded” an adequate warning and not used it. But we know that’s simply not true. For example, millions still smoke cigarettes, although those risks have been public knowledge for decades. Millions more use drugs and medical devices even though they carry the FDA’s strongest “black box” warnings. A “heeding presumption” in this situation is contrary to fact and to common sense. For that reason, some courts treat the heeding presumption in prescription medical product cases as meaning only that the prescribing physician would have factored the additional information in an “adequate” warning into his or her decisionmaking calculus. E.g., Eck v. Parke, Davis & Co., 256 F.3d 1013, 1021 (10th Cir. 2001) (wrong to “construe [a treater’s] ‘heeding’ an adequate warning to mean [s/he] would have given the warning”) (applying Oklahoma law); In re Diet Drug Litigation, 895 A.2d 480, 490-91 (N.J. Super. Law Div. 2005).

Heeding presumptions are something that exists in some states (Massachusetts, Missouri, Oklahoma), doesn’t in others (California, Connecticut, Alabama), and is limited in still others (New, Jersey, Pennsylvania, Texas). A reader recently suggested (we apologize, we seem to have lost that email) that we do a 50-state survey of where the various states stand on this subject – along the lines of the post we did in 2008 on informal interviews with treating physicians.

We thought that was a good idea, although it took us more time than we had hoped to put this together. So what follows is our best interpretation of the position of the fifty states (plus DC and Puerto Rico) on whether any presumption arises when a plaintiff claims an inadequate warning (almost every case) that a hypothetical warning (never in fact given) would have been heeded.

One thing we have discovered of particular note (at least to us), is that the heeding presumption is an area where the federal courts have run amok, ignoring their obligations under the Erie Doctrine to leave major expansions of state-law liability – flipping the burden of proof in warning cases certainly qualifies – to state courts. By our count, federal judges have trampled over state sovereignty with respect to the heeding presumption in no fewer than eleven states – Alaska, Colorado (despite contrary state-court authority), Georgia, Hawaii, Illinois, Iowa, Kentucky, Maine, New York (despite contrary state-court authority), South Dakota, and Wyoming.

Finally, because various states have taken quite different approaches to whether a heeding presumption exists at all and if so how it is applied, careful counsel will want to consider in appropriate circumstances the application of choice of law principles to such presumptions. See Restatement (Second) of Torts §134 & comment b (1970).

Restatement of Torts

The heeding presumption is derived from language in Restatement (Second) of Torts §402A, comment j (1965) that dealt with the opposite situation − presuming that an adequate warning, when given, will be read and heeded. “Where warning is given, the seller may reasonably assume that it will be read and heeded.” Id. That helped defendants, but not much, in warning claims since when warnings are adequate, defendants win anyway. It was actually more directed to the effect of warnings on design defect claims than on warning claims themselves. Courts wasted no time, however, in turning that presumption on its head, and creating something that the Restatement’s drafters had never contemplated, a presumption that whenever a warning wasinadequate, any adequate alternative offered by the plaintiff would have been read and heeded. This helped plaintiffs a lot, since it effectively eliminated their burden of proving causation.

When the Restatement (Third) of Torts, Products Liability §2 (1998) superseded §402A, however, no such presumption was recognized at all in any context. Quite the contrary, Third Restatement’s drafters criticized comment j’s presumption language as “unfortunate” and stated that it shouldn’t be followed. See Restatement (Third) of Torts, Products Liability §2, reporters notes to comment l (1998). To the extent that a particular jurisdiction that previously permitted a heeding presumption with reference to Restatement §402A, comment j has subsequently adopted the Third Restatement, it can be argued that the heeding presumption has been/should be abolished.

Alabama

There is no heeding presumption in Alabama. A “failure-to-warn-adequately case should not be submitted to the jury unless there is substantial evidence that an adequate warning would have been read and heeded and would have prevented the accident.” Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991). AccordGurley v. American Honda Motor Co., 505 So.2d 358, 361 (Ala. 1987) (cited in Deere). SeeBarnhill v. Teva Pharmaceuticals USA, Inc., 819 F. Supp.2d 1254, 1262 (S.D. Ala. 2011) (“Alabama courts have not recognized such a [heeding] presumption”) (citing Deere).

Alaska

In an nonprecedential, memorandum opinion, the Ninth Circuit predicted that the Alaska Supreme Court would adopt the heeding presumption because of that court’s history of following Restatement comments generally. Ellis v. Coleman Co., 2000 WL 1131893, at *2 (9th Cir. 2000) (in table at 232 F.3d 894). Ellis is non-citable under Ninth Circuit rules, and since then no Alaska court has followed it.

Arkansas recognizes a heeding presumption. Bushong v. Garman Co., 843 S.W.2d 807, 811 (Ark. 1992). “This presumption may be rebutted by evidence which persuades the trier of fact that an adequate warning or instruction would have been futile under the circumstances.” Id. This presumption was applied to pharmaceutical cases in In re Prempro Products Liability Litigation, 586 F.3d 547, 569 (8th Cir. 2009) (applying Arkansas law). Most presumptions in Arkansas “disappear” once “the opponent does offer evidence to the contrary.” Orient Insurance Co. v. Cox, 238 S.W.2d 757, 763 (Ark. 1951). This rule has not been applied, either way, to the heeding presumption in Arkansas as far as we can tell.

Plaintiff has cited no California case using comment j to shift either the burden of proof as to causation or the burden of going forward to a defendant in a failure-to-warn case. Moreover, even if California had adopted the rebuttable presumption in failure-to-warn cases generally, California courts would not necessarily apply that presumption in the prescription drug context, which raises distinct policy concerns.

A Colorado appellate court rejected a general heeding presumption in Potthoff v. Alms, 583 P.2d 309, 311 (Colo. App. 1978), and although Colorado courts have applied the comment j presumption as written, they have yet to apply any “converse” heeding presumption to help plaintiffs. None of that, however stopped the Tenth Circuit from stating (in dictum; the case wasn’t about a plaintiff’s heeding a warning) that such a presumption existed in Colorado in Staley v. Bridgestone/Firestone, Inc., 106 F.3d 1504, 1509 (10th Cir. 1997). Applying Colorado law in a prescription medical product case, the court in In re NuvaRing Litigation, 2013 WL 1874321 (N.J. Super. Law Div. April 18, 2013), held that “[n]o heeding presumption exists to temporarily shift the burden to Defendants.” Id. at *26.

Connecticut

There is no heeding presumption in Connecticut. As discussed inDeJesus v. Craftsman Machine Co., 548 A.2d 736 (Conn. App. 1988), a statute, C.G.S. §52-572q(c), “specifically places upon [plaintiff] the burden of proving proximate cause.” 548 A.2d at 744. The statute states,” “the claimant shall prove by a fair preponderance of the evidence that if adequate warnings or instructions had been provided, the claimant would not have suffered the harm.”

Delaware

Since Delaware never adopted strict liability or Restatement (Second) of Torts §402A (1965), no heeding presumption has been recognized under Delaware law.

Oddly, given the size of the state, we found nothing discussing the heeding presumption in any product liability case under Florida law. The warning causation discussion in Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (applying Florida law), suggests that no such presumption applies, at least in the context of prescription medical products.

Georgia

As far as we can tell, no Georgia appellate court has ever ruled on whether, in general, a heeding presumption should be adopted in any product liability case. We’d call the question “open.” A couple of trial courts, in dictum, have purported to recognize some sort of a “burden shifting” in pharmaceutical warning defect cases. In both cases, the purported presumption, if that’s what it is, was rebutted as a matter of law and summary judgment was entered – and affirmed on appeal.

[T]he court assumes that Georgia will apply the presumption in comment j to §402A. The court finds that there is no indication in Georgia law, however, that it would apply this comment in the manner of a “heeding presumption” that would vitiate the need for a plaintiff to establish proximate cause for her injuries.

Id. at *11. The same type of physician testimony that defeats causation under the learned intermediary rule also rebuts the any burden-shifting presumption. Id. at *12; accordDietz v. SmithKline Beecham Corp., 2008 WL 5329295, at *3-4 (N.D. Ga. Dec. 9, 2008) (same result as in Deitz; also holding that any presumption does not affect applicabilty of learned intermediary rule), aff’d, 598 F.3d 812 (11th Cir. 2010).

We found nothing adopting, or rejecting, a product liability heeding presumption in Idaho – only hundred-year-old train whistle cases making the same point that the ALI did in §402A, comment j (and not the judicially invented converse).

Some federal courts had charged in where Illinois state courts have yet to tread. Most egregious is Rutz v. Novartis Pharmaceutical Corp., 2012 WL 6569361 (S.D. Ill. Dec. 17, 2012), which went ahead and applied a presumption even after admitting that “the issue of whether a ‘heeding presumption’ applies has not been clearly addressed by the Illinois Supreme Court.” Id. at *7. Likewise, in Erickson v. Baxter Healthcare, Inc., 151 F. Supp.2d 952 (N.D. Ill. 2001), the court, citing Mahr, applied a heeding presumption under Illinois law. Id. at 970. The entire analysis inErikson is one sentence: “In any event, the plaintiffs are entitled at this stage to a presumption that a learned intermediary would have heeded the warnings given.” Id.See alsoMason v. Smithkline Beecham Corp., 2010 WL 2697173, at *9 (C.D. Ill. July 7, 2010) (discussing but not deciding heeding presumption issue; finding disputed issue of fact); Giles v. Wyeth, 500 F. Supp.2d 1063, 1069 (S.D. Ill. 2007) (same).

Indiana

An intermediate Indiana appellate court was an early adopter of the heeding presumption. Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 555 (Ind. App. 1979) (“[w]here warnings are inadequate, however, the presumption [in comment j] is in essence a presumption of causation”). However, that presumption does not do away with the plaintiff’s obligation to prove causation:

[T]he “read-and-heed” presumption does not completely dispose of the causation issue in a failure-to-warn case. The most the presumption does is establish that a warning would have been read and obeyed. It does not establish that the defect in fact caused the plaintiff's injury. The plaintiff invoking the presumption must still show that the danger that would have been prevented by an appropriate warning was the danger that materialized.

Presumptions of this type are not regarded as evidence but rules of law which guide the order of proof and establish the bounds of a prima facie case. Once the duty of going forward with evidence has been discharged, the presumption is functus officioand has no proper place in jury instructions.

Without any guidance from Iowa state courts, federal courts have adopted a limited heeding presumption – one not applicable to “learned intermediary” situations.

We affirm the district court's application of a rebuttable presumption to the proximate cause issue. The district court relied on the factual distinctions between the physician-patient situation . . . and the mass-immunization context of this case to justify the use of the rebuttable presumption.

For its part, the Iowa Supreme Court still hasn’t considered the heeding presumption. However, since Iowa has since adopted the Third Restatement of Torts, and the court has specifically discussed the Third Restatement’s rejection of §402A, comment j, we think it’s unlikely to follow the federal courts down this road. SeeLeaf v. Goodyear Tire & Rubber Co., 590 N.W.2d 525, 528-29 (Iowa 1999).

Under the Maryland rule . . . a presumption continues to exist as a question for the jury once evidence is introduced to meet or rebut it, unless the Court determines that the rebuttal evidence overcomes the presumption as a matter of law.

[D]efendant must then come forward with sufficient evidence to rebut that presumption, and . . . once the presumption is rebutted, plaintiff must produce sufficient evidence to create a triable issue on the question of causation.

There is no heeding presumption in Michigan. The closest any Michigan court has come is Allen v. Owens-Corning Fiberglas Corp., 571 N.W.2d 530 (Mich. App. 1997), which permitted an “inference,” not a “presumption” of causation in certain warning defect cases where “the lack of warning is undisputed, and the person exposed is dead.” Id. at 535. In a prescription drug case, the same court held, “the plaintiff does have the burden of proving that had [the prescriber] been adequately warned he would have pursued a course of treatment to avoid or reduce injury.” Muilenberg v. Upjohn Co., 320 N.W.2d 358, 366 (Mich. App. 1982).

Urged to create this novel presumption for Mississippi, the Fifth Circuit refused in Thomas v. Hoffman–La-Roche, Inc., 949 F.2d 806 (5th Cir. 1992). “No Mississippi court has adopted a presumption of causation on facts similar to those in this case, and the failure of the Mississippi Supreme Court to mention such a presumption in [a similar case] strongly suggests that such a presumption does not exist under Mississippi law.” Id. at 813. Thomas went on to discuss more thoroughly than any other court why the heeding presumption is a particularly bad idea with respect to products, such as prescription medical products, where warnings are about inherent risks, since “heeding” amounts to not using such products at all:

[W]e recognize that there are two very different types of warnings that might be associated with a particular product: (1) an unavoidable risk warning; and (2) a preventable risk warning. The first type of warning details a risk that a consumer cannot avoid if the consumer chooses to use the product. Typically, warnings associated with medical drugs fall into this category. . . . The only question for the potential consumer of [such a] product is whether the potential benefit to be obtained from using the product outweighs this risk. . . .

Typically, the choice facing the user in the preventable risk situation is between using the product safely and using the product unsafely. The choice, however, presented by an unavoidable risk warning is not between the safe use and the unsafe use of a product, but between using and not using the product. The consumer can choose to use the product and face its risks, or choose not to use the product and lose its potential benefits. Generally, using the product will present the less risky of these two alternatives. . . . Unless the plaintiff can establish that using the product is, for the average consumer, the more risky alternative, the [same rule] would seem to establish a rebuttable presumption that the consumer would not have changed his decision to use the product if warned of the unavoidable risk.

For this reason, we reject [plaintiff’s] contention that causation is presumed, given an inadequate warning, in the context of an unavoidable risk. . . . We are willing to assume that the failure to give an adequate warning of a known risk entitles the plaintiff to a rebuttable presumption that the learned intermediary would have read and heeded a proper warning. But “heed” in this context means only that the learned intermediary would have incorporated the “additional” risk into his decisional calculus.

Id. at 813-14 (footnotes and citations omitted). SeeSmith v. Johnson & Johnson, 2011 WL 3876997, at *11 (S.D. Miss. Aug. 31, 2011) (“[t]he burden remains on the plaintiff to demonstrate that the additional non-disclosed risk was sufficiently high that it would have changed the treating physician’s decision to prescribe the product for the plaintiff”), aff’d, 483 F. Appx. 909 (5th Cir. 2012).

There is no heeding presumption in Montana. In Riley v. American Honda Co., 856 P.2d 196, 199-200 (Mont. 1993), the court held:

We are unwilling to shift the respective parties’ burdens in such a fashion. In order to rebut a presumption of causation, the defendant would need to prove that the warning would not have altered the plaintiff’s conduct or that the plaintiff’s own negligence caused the injury. A defendant certainly is in no better position to rebut a presumption which totally excuses a plaintiff from meeting the causation element than a plaintiff is in establishing the causation element as part of the prima facie case.

Id. at 200.

Nebraska

No Nebraska case has ever discussed the heeding presumption, as far as we know.

[W]e conclude that Nevada law does not support recognizing a heeding presumption. It is a firmly rooted part of Nevada law that the plaintiff in a strict product liability case bears the burden of proving all the elements of his case, including causation.

Id. at 277.

New Hampshire

New Hampshire does not have a heeding presumption. In Wilson v. Bradlees of New England, Inc., 250 F.3d 10 (1st Cir. 2001), the First Circuit, exercising proper Erie restraint, recognized “that New Hampshire had not adopted the ‘read and heed’ presumption and we will not do so on its behalf.” Id. at 15-16. Cf.Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp. 2d 135, 147 (D.N.H. 2010) (recognizing that any heeding presumption was “questionable” after Wilson; holding that any presumption had been rebutted by the prescriber’s failure to read), aff’d on other grounds, 678 F.3d 30 (1st Cir. 2012), rev’d on other grounds, 133 S. Ct. 2466 (2013).

[W]e do agree with [defendant] that . . . the judge’s use of the heeding presumption in her legal analysis and jury instructions was not legally required. That presumption, precedent demonstrates, is primarily applicable in circumstances in which plaintiff lacks the ability to prove by direct evidence that a proper warning, if given, would have been heeded. But here, direct evidence in the form of the deposition testimony of [plaintiff’s] treating physician existed, rendering use of a presumption unnecessary.

Id. at 269 (citation omitted) (emphasis added).

The New Jersey heeding presumption is rebuttable:

If, however, the defendant presents rebuttal evidence such that reasonable minds could differ as to whether the warning, if given, would have been heeded by the plaintiff, the defendant has satisfied its burden of production and the plaintiff loses the benefit of the presumption.

Sharpe, 713 A.2d at 1086. If entirely unrebutted, the heeding presumption allows a court to “determine as a matter of law that the warning would have been heeded.” Coffman, 628 A.2d at 716.

The heeding presumption has been applied under New Jersey law in a number of prescription medical product cases. In McDarby, discussing Strumph v. Schering Corp., 626 A.2d 1090 (N.J. 1993), the court acknowledged that prior prescriber awareness of relevant risks was a situation where “the presumption would have been rebutted as a matter of law.” 949 A.2d at 268. The presumption may be rebutted, in a prescription medical product case, with “evidence that . . . the plaintiffs’ health care professionals, if provided with the warning information, would have prescribed [the drug] anyway and would not have communicated the risk information . . . to the plaintiffs.” In re Diet Drug Litigation, 895 A.2d 480, 492 (N.J. Super. Law Div. 2005) (pre-McDarbydecision). SeeBaker v. App Pharmaceutical LLP, 2012 WL 3598841, at *9 (D.N.J. Aug. 21, 2012) (holding presumption rebutted as a matter of law due to prior prescriber knowledge and failure to read drug warnings).

The situation in New York is extremely murky. The New York Court of Appeals has never addressed the heeding presumption. Some time ago, the Second Circuit described matters thusly, concluding that the purported presumption was nothing more than a permissible jury inference:

[Plaintiff] somewhat misstates the matter by asserting that New York recognizes a “heeding presumption,” but she is correct in contending that in some circumstances, New York permits the trier to infer that a warning would have been heeded and thereby to conclude that the absence of a warning that was reasonably required to be given was a proximate cause of an injury. Appellee cites no New York decision that refers to a “presumption” of heeding.

Raney v. Owens-Illinois, Inc., 897 F.2d 94, 95 (2d Cir. 1990) (applying New York law); SeeTopliff v. Wal-Mart Stores E. LP, 2007 WL 911891, at *43 (N.D.N.Y. Mar. 22, 2007) (given Raney, court was”skeptical of Plaintiff's characterization of the failure-to-warn law in New York as providing a “presum[ption] that a user would have heeded the warnings if they had been given”). The situation rather reminds us of the morass that existed with respect to medical monitoring before the Court of Appeals put that issue to rest in Caronia v.Philip Morris.

Other courts applying New York law are incompatible with any heeding presumption. The Appellate Division held, in a prescription medical product case:

Contrary to plaintiff's argument, in this State, it remains plaintiff's burden to prove that defendant’s failure to warn was a proximate cause of his injury (and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given.

In a failure-to-warn action, a plaintiff bears the burden to prove that defendant’s failure to warn was a proximate cause of his injury and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given. In the case of prescription medications, where warnings are directed to prescribing physicians, a plaintiff must demonstrate that had a different, more accurate warnings been given, his physician would not have prescribed the drug in the same manner.

Alston v. Caraco Pharmaceutical, Inc., 670 F. Supp.2d 279, 285 (S.D.N.Y. 2009) (citation to Sosna omitted). AccordReis v. Volvo Cars, Inc., 901 N.Y.S.2d 10, 13 (App. Div. 2010) (“failure to warn claims should have been dismissed because . . . there is no proof in the record that [plaintiff] would have read and heeded a warning”);Santos v. Ford Motor Co., 893 N.Y.S.2d 537, 538 (N.Y.A.D. 2010) (quoting Sosna); Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D. 2007) (“well settled law” imposes on plaintiffs “the obligation to adduce proof that had a warning been provided, she would have read the warning and heeded it”); Perez v. Radar Realty, 824 N.Y.S.2d 87, 89 (N.Y.A.D. 2006) (“Plaintiff testified that he made no attempt to read or to obtain assistance in reading the product label and, accordingly, the alleged labeling deficiency could not have caused the complained-of harm.”); Menna v. Walmart, 2013 WL 3958247, at *3 (N.Y. Sup. Ct. 2013) (“no proof that the plaintiff would have read and heeded a warning about any risk”); Hayes v. New York, 2013 WL 5278879, at *15 (N.D.N.Y. Sept. 18, 2013) (“Plaintiff has failed to offer any evidence that even if a different warning had been issued, the user of the product . . . would have read and heeded that warning”); In re Nuvaring Litigation, 2013 WL 1874321, at *33 (N.J.Super. L. D. April 18, 2013) (following Mullhall; burden on plaintiff) (applying New York law).

New York cases applying a heeding presumption recognize that it is “rebutted by specific facts showing that the warning would have been futile.” Bee, 2014 WL 1855632 at *12; Saladino, 704 F. Supp.2d at 249; Santoro, 340 F. Supp.2d at 486.

[Where a defendant can show, via “specific facts,” that any given warning would have been futile − either because any such warnings would not have been heeded or because the injury would have occurred, regardless of the given warnings − a defendant will have successfully rebutted the general presumption

Bee, 2014 WL 1855632, at *12

One such set of rebuttal facts is where the party to be warned “was fully aware of the hazard through general knowledge, observation or common sense.” Id.; accordMonel, 895 F. Supp.2d at 414. Also, “the presumption that a user would have heeded warnings can be rebutted by proof that an adequate warning would have been futile since plaintiff would not have read it.” Power v. Crown Controls Corp., 568 N.Y.S.2d 674, 675 (N.Y. Sup. Ct. 1990). A third set of facts is where “the risk was well understood . . . and therefore a warning would have made no difference.” Ramos v. Simon-Ro Corp., 2008 WL 4210487, at *12 (S.D.N.Y. Sept. 11, 2008).

North Carolina

We found no North Carolina case ever adopting (or rejecting) the heeding presumption. That’s not as surprising as it sounds, because North Carolina is one of a few states that never adopted strict liability, and thus §402A, at all. Indeed, North Carolina has a statute forbidding strict liability. N.C.G.S.A. §99B-1.1.

The presumption is rebuttable under the usual “more likely than not” evidentiary standard. Crowston, 521 N.W.2d at 410. Evidence of the plaintiff’s anti-social character, otherwise inadmissible, is admissible to rebut the presumption. Id. at 411. In a prescription medical product case “[t]he presumption that had an adequate warning been given it would have been read and heeded is rebutted by plaintiff’s testimony that he did not read the warning.” Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *3 n.3 (D.N.D. Sept. 5, 2000). Also sufficient to rebut the presumption is evidence that the prescriber “knew the risks of prescribing” and continues to do so. Ehlis v. Shire Richwood, Inc., 233 F. Supp.2d 1189, 1196-97 (D.N.D. 2002), aff’d, 367 F.3d 1013 (8th Cir. 2004)

Where, as here, an adequate warning would have made no difference in the physician’s decision as to whether to prescribe a drug or as to whether to monitor the patient thereafter, the presumption . . . is rebutted, and the required element of proximate cause between the warning and ingestion of the drug is lacking.

All common-law presumptions in Ohio are of the “bubble bursting” variety under Ohio R. Evid. 301. Forbes v. Midwest Air Charter, Inc., 711 N.E.2d 997, 999 (Ohio 1999). “[T]he effect of rebutting the presumption [is] ‘bursting the bubble,’ with the case then proceeding as if the presumption had never arisen.” Horsley v. Essman, 763 N.E.2d 245, 249 (Ohio App. 2001); accord, Forbes, 711 N.E.2d at 999 (holding that where evidence “was presented” jury should not have been charged on presumption).

In prescription medical product liability cases, “[d]efendants can rebut this presumption by showing that the prescribing doctor had knowledge of the risks associated with a particular drug.” Shepherd v. Eli Lilly & Co., 497 F. Appx. 143, 145 (2d Cir. 2012) (applying Oklahoma law). Defendants may also “rebut this presumption by establishing that although the prescribing physician would have ‘read and heeded’ the warning or additional information, this would not have changed the prescribing physician's course of treatment.” Stafford v. Wyeth, 411 F. Supp. 2d 1318, 1320-21 (W.D. Okla. 2006) (citation and quotation marks omitted). A prescriber’s testimony that s/he “would still have prescribed” even knowing some then-unknown information also rebuts the presumption. Eck, 258 F.3d at 1021; Ingram, 888 F. Supp.2d at 1245.

[I]t is entirely proper in the context of a “learned intermediary” case to consider the affidavit or testimony of the actual treating physician in determining whether a manufacturer of a particular prescription drug has overcome the presumption that the treating physician would have heeded a proper warning and not prescribed the drug in question.

Woulfe v. Eli Lilly & Co., 965 F. Supp. 1478, 1485 (E.D. Okla. 1997).

Oregon

In McPike v. Enciso’s Cocina Mejicana, Inc., 762 P.2d 315, 319 (Or. App. 1988), the court held that a plaintiff was “not entitled to have the jury instructed about the existence of the putative [heeding] presumption. Id. at 319. Thus, “there is not a presumption under Oregon law that an adequate warning would have been read and prevented the harm.” Parkinson v. Novartis Pharmaceutical Corp., 5 F. Supp.3d 1265, 1272 (D. Or. 2014).

When applicable, the heeding presumption in Pennsylvania is rebuttable:

While the heeding presumption benefits a failure to warn plaintiff, it does not change the fact that he still bears the burden of persuasion. . . . “The heeding presumption [is] rebuttable, and thus, when the opponent of the presumption has met the burden of production thus imposed . . . the office of the presumption has been performed; the presumption is of no further effect and drops from the case.”

In another example of federal courts running roughshod over the limits of their diversity jurisdiction, the Eighth Circuit predicted South Dakota would follow a heeding presumption in Schilf v. Eli Lilly & Co., 687 F.3d 947, 949 (8th Cir. 2012), a prescription drug case, simply because it had previously predicted that the state would adopt other parts of Restatement §402A, comment j.

Tennessee

In Payne v. Novartis Pharmaceuticval Corp., 767 F.3d 526 (6th Cir. 2014), the Sixth Circuit discussed the heeding presumption as applied in other states and concluded that “Tennessee has not adopted any of these presumptions.” Id. at 533. Nothing we have found is to the contrary.

In Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008) (a Herrmann/Bexis collaboration), the Fifth Circuit looked at this history and concluded that the Texas heeding presumption (assuming it existed at all after Texas adopted the Third Restatement) does not apply in any prescription medical product case:

[N]either Texas nor federal courts applying Texas law have applied the read-and-heed presumption to pharmaceutical cases involving learned intermediaries. In fact, Texas has explicitly rejected . . . Comment j's “read-and-heed” presumption for policy reasons and because it has been superseded by Restatement (Third) of Torts: Products Liability §2. Additionally, the relevant cases show the plaintiff bore the burden of showing that the inadequacy of the warning was a producing cause of injury.

Further, we doubt the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. The read-and-heed presumption has been justified because it excuses plaintiff from the necessity of making self-serving assertions that he would have followed adequate instructions. . . . In the learned-intermediary context, however, it is [the prescriber], not [plaintiff], who had to testify about his decision to prescribe [the drug].

Utah has adopted the presumption against preemption, using the Restatement §402A, comment j rationale. House v. Armour of America, Inc., 929 P.2d 340, 347 (Utah 1996). As in every other state, the presumption is rebuttable. Id.; accordDowdy v. Coleman Co., 2013 WL 949495, at *1 (D. Utah Mar. 11, 2013) (rebutted by failure to follow other warnings about product).

House expressly distinguished the “unavoidable” risk situation typically of prescription medical products. 929 P.2d at 347 (holding that risk in question was not “truly unavoidable”). Once again, federal courts have not been so reticent. In Tingey v. Radionics, 193 F. Appx. 747 (10th Cir. 2006), the court, without discussion, extended the heeding presumption to a medical device. Id. at 759.

A presumption, of itself alone, contributes no evidence and has no probative quality. It takes the place of evidence, temporarily, at least, but if and when enough rebutting evidence is admitted to make a question for the jury on the fact involved, the presumption disappears and goes for naught. In such a case, the presumption does not have to be overcome by evidence; once it is confronted by evidence of the character referred to, it immediately quits the arena.

Menard, 373 A.2d at 506-07 (presumption rebutted by failure to follow instructions) (citation and quotation marks omitted); accordBridport, 693 A.2d at 704. “[I]f the manufacturer can show that the user was warned of the risk and chose to ignore the warning, the presumption disappears, because there is no reasonable basis to assume that the user would have heeded a warning from the manufacturer.” Kellogg v. Wyeth, 762 F. Supp. 2d 694, 701 (D. Vt. 2010).

We weren’t able to find any Washington state court decision adopting a heeding presumption. We did find this:

[Plaintiff] also encourages the Court to adopt the “read and heed” presumption. . . . Under this doctrine, a court will presume that had adequate warning been given it would have been heeded. This presumption is not currently recognized in Washington law, which law the Court must apply in this case.

“West Virginia does not apply a heeding presumption.” In re NuvaRing Litigation, 2013 WL 1874321, *35-36 (N.J. Super. Law Div. April 18, 2013). That appears to be the case, as we have been able to locate any state or federal West Virginia case employing a heeding presumption.

Wisconsin

The Wisconsin Supreme Court has never discussed the heeding presumption, and the Court of Appeals has swung both ways. InTanner v. Shoupe, 596 N.W.2d 805, 817-18 (Wis. App. 1999), the court relied upon a comment j heeding presumption. However, in a more recent prescription medical product case, the same court held, that “[e]ven in the event that a warning is inadequate, proximate cause is not presumed.” Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. App. 2004) (patient ignored drug warnings to seek medical attention if certain symptoms developed). SeeMenges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999) (“a plaintiff must not only show that a manufacturer's warning was inadequate, but that such inadequacy affected the prescribing physician's use of the product”) (applying Wisconsin law).

In Michaels v. Mr. Heater, Inc., 411 F. Supp.2d 992 (W.D. Wis. 2006), an expansive-minded federal court decided to follow Tannerrather than Kurer. 411 F. Supp.2d at 1006. Both Tanner andMichaels involved non-prescription products, which meant that “the facts of this case are more analogous to those confronted by the court in Tanner than in Kurer. 411 F. Supp.2d at 1007. However, a few months after Michaels, the Wisconsin Court of Appeals again took the Kurer route, this time in a non-prescription medical product case, holding “[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury.” Schreiner v. Wieser Concrete Products, Inc., 720 N.W.2d 525, 528 (Wis. App. 2006).

Most recently, in the 2011 the Wisconsin legislature enacted tort reform, requiring “the claimant” in all product liability cases to “establish[] all of the following by a preponderance of the evidence” including, “[t]hat the defective condition was a cause of the claimant’s damages.” Wis. Stat. §895.047(1)(e). If a heeding presumption ever existed under Wisconsin law, this statutory assignment of the burden of proof on causation should kill it.

Wyoming

In the absence of any Wyoming precedent, the court in Thom v. Bristol-Myers Squibb Co., 353 F.3d 848 (10th Cir. 2003) (applying Wyoming law), predicted that the state would apply a heeding presumption in a prescription medical product case. Id. at 855-56. The presumption was rebuttable by “testimony that a different warning would not have made a difference in the actions of the physician.” Id. at 855. Such rebuttal evidence includes “when a physician fails to read or rely on a drug manufacturer's warnings,”id. at 856, but Thom found the evidence inconclusive. Id. at 857.

During the ensuing decade, no Wyoming court has followed Thomas to the heeding presumption.

Finally, we’ve seen a number of courts, such as Thom, make statements to the effect that the heeding presumption is recognized in a “vast majority of jurisdictions.” 353 F.3d at 855. As we hope the above analysis has demonstrated, that’s simply not so.

By our count, the heeding presumption has been adopted by a state court (at any level) in nineteen jurisdictions: Arizona, Arkansas, the District of Columbia, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Missouri, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Vermont, and Wisconsin. In four of those states (New Jersey, Pennsylvania, Texas, and Wisconsin) the heeding presumption has either been abolished by statute (Wisconsin) or eliminated in all (Pennsylvania, Texas) or most (New Jersey) cases involving prescription medical products. In New York (as in pre-statute Wisconsin), there is at least as much state-court authority against the heeding presumption as in favor of it. So in the prescription medical product area, there are fourteen jurisdictions that allow a generally applicable heeding presumption in the drug/device cases that we typically defend..

By contrast, the laws of seventeen jurisdictions have refused to adopt the heeding presumption in any kind of case: Alabama, California, Colorado, Connecticut, Michigan, Minnesota, Mississippi, Montana, Nevada, New Hampshire, North Carolina, Oregon, South Carolina, Tennessee, Virginia, Washington, and West Virginia. Add post-statute Wisconsin to that list and the number is eighteen. There’s also plenty of New York law generally rejecting the heeding presumption, which would make nineteen.

If we’re discussing prescription medical product liability cases specifically, then to that nineteen, we would then add the three states (New Jersey, Pennsylvania, and Texas) that have excluded otherwise applicable heeding presumptions from all or most such cases. Thus, in prescription medical product case, specifically, jurisdictions rejecting a heeding presumption outnumber those recognizing it by 22-14, or at least 21-15, depending on how New York is counted.

There is essentially no law at all in seven jurisdictions: Delaware (which never had strict liability), Florida (where the lack of precedent most surprises us), Idaho, Nebraska, New Mexico, Puerto Rico, and Rhode Island. If we were to add those to the “no” column, that would raise the number of no-heeding presumption jurisdictions to as many as 29.

Thus the only way that the heeding presumption can reach any sort of majority – let alone a “vast” one – is to include the nine jurisdictions in which federal courts have improperly predicted the expansion of state tort liability by recognizing a heeding presumption in the absence of any supporting state-court precedent: Alaska, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maine, South Dakota, and Wyoming. To those, we’ll also mention the two states (Colorado and New York) where federal courts have made predictions despite contrary state intermediate court authority. In Iowa, the federal prediction does not extend to cases involving prescription medical products that physicians actuallly prescribed.

On top of all that, almost every early adopter of the heeding presumption did so on the basis of language in Restatement (Second) of Torts §402A, comment j (1965), that (as we discussed at the beginning of this post) is not only omitted but specifically repudiated in the Third Restatement of Torts. Restatement (Third) of Torts, Products Liability §2, reporters notes to comment l (1998). All of the states adopting the heeding presumption did so prior to the ALI's adoption of the Third Restatement, except Pennsylvania (which followed a pre-Third Restatement federal decision). Conversely, no state appellate court, with that one exception, has made an initial decision to adopt a heeding presumption since the ALI gave comment j its seal of disapproval in 1998..

Compare jurisdictions:Litigation: Enforcement of Foreign Judgments

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